This present invention relates to soft tissue body augmentation, for example the face, breast, buttock, and other body parts.
Augmenting or changing the shape of the soft tissue of the human body has been done previously in medicine by harvesting donor tissue from one part of the body then processing and introducing it to another desired part of the body or by using implants. The donor tissue is usually adipose or fatty tissue or muscle and the harvesting of the donor tissue is time consuming and often leaves an unwanted defect and scars from the harvested site. The procedure time is lengthened with the harvesting and processing of the tissue and adds greatly to the cost of the procedure and the recovery time is also prolonged. The donor tissue will then have to be placed in the desired area usually through surgical means which can be lengthy and costly and usually laves a large scar as in the case of the breast or buttocks (butts).
Reconstruction of the human breast or butt involves introducing a fixed or changeable-volume sac-like silicone rubber structure into a body cavity surgically created to receive such an implant. The implants and coverings therefore are described, by way of illustration and not by limitation, in: Braumann U.S. Pat. No. 4,648,880; Hamas U.S. Pat. No. 4,531,244; Ledergerber U.S. Pat. No. 4,955,907, Corbitt U.S. Pat. No. 6,881,226, Kinsley U.S. Pat. No. 6,981,988, and Studin U.S. Pat. No. 7,137,995, the contents of which are incorporated by reference.
Known methods of augmentation mammoplasty utilize silicone or saline implants. These methods have been complicated post-operatively by encapsulation of the implants, which can occur to varying degrees. Encapsulation produces a hard area of scar tissue around the implant, resulting in a rigid, abnormally-shaped mound beneath the breast or butt tissue or pectoralis muscle, depending upon the placement of the implant.
The usual skin incision is on the order of 3-8 centimeters in length and is stretched open with retractors to facilitate the introduction of the implant. In various surgical procedures, a breast or butt implant is placed within the surgically formed body cavity for subsequent inflation and/or deflation with a fluid.
In plastic and reconstructive surgery, when a breast or butt implant or tissue expander is placed in the dissected pocket, it is typically filled via a fill connector coupled to fill tubing which is attached to a filling material (e.g. saline solution) source.
There are currently three basic types of fill connectors used to connect the fluid source to the implant, the choice of which often depends on the implant and the particular surgical approach used. The first is a permanent attachment of the fill tubing to the implant. A common means for this attachment is to make a small opening within the body or shell of the implant and insert the tubing securing it by means of connecting materials such as sleeves, patch assemblies, adhesives or vulcanizing compounds.
The other two common connectors are for temporary attachment of the fill tubing to the implant by means of a valve in the implant which seals after the fill tubing is removed. One of these two temporary attachment means is most commonly used with saline-fill breast or butt implant devices that include a diaphragm valve within the shell. The valve has an opening that requires a rigid male implement to be inserted in the opening thus opening the valve and allowing fluid transfer. This male implement is the fill tip end of the fill connector, which has on the opposite end one or more barbs which accept the flexible (e.g. silicone or vinyl) fill tubing. In use, the fill connector and fill tubing attach to the implant normal to the implant surface.
Since breast or butt implants are usually placed into the body through incisions considerably smaller than the implant, it has always been a challenge to introduce them. With greatly increased friction at the interface between the surface of newer texturized implants and the wound margins (body tissue), it has become correspondingly more difficult to introduce these implants. Increased manipulation of both implants and patient tissue often results in trauma to both implants and patient tissue, thereby increasing the risk associated with the procedure both in terms of immediate consequences as well as delayed structural failure and the implications deriving therefrom. Postoperative infection has also been a troublesome consequence of the need to manipulate the implant into place.
In a related art, U.S. Pat. No. 7,491,709 discloses methods of providing long-term minimization of wrinkles or folds in the skin by injecting a bolus of hyaluronic acid deep into the skin. The methods are particularly beneficial for improving the contours of the cheeks, filling folds under the eyes, and providing the visual effect of a chin implant, without requiring the use of surgical procedures.
United States Patent Application 20090240200 discloses a system for inserting a distal end portion of a needle of a medical injector into a skin of a body. An energy source operatively coupled to the medical injector is actuated such that a dermal filler is conveyed from the medical injector into the skin through the distal end portion of the needle. The distal end portion of the needle is moved within the skin during the actuating.